Cabotegravir + Rilpivirine Long-Acting: Overview of Injection Guidance, Injection Site Reactions, and Best Practices for Intramuscular Injection Administration

• Published in: Open forum infectious diseases 2024-06, Vol.11 (6), p.ofae282-ofae282
• Main Authors: Teichner, Paula, Chamay, Nadine, Elliot, Emilie, Pascual-Bernáldez, Miguel, Merrill, Deanna, Garris, Cindy, D'Amico, Ronald, Felizarta, Cecy, Torres, Emma, Van Solingen-Ristea, Rodica, Baugh, Bryan, Patel, Parul, Vannappagari, Vani, Dakhia, Samia, Polli, Joseph W, Garside, Louise, Grove, Richard, Thiagarajah, Shanker, Birmingham, Eileen, van Wyk, Jean
• Format: Article
• Language: English
• Subjects: Clinical Trials and Therapeutics
• ISSN: 2328-8957; 2328-8957
• DOI: 10.1093/ofid/ofae282

Cabotegravir (CAB) + rilpivirine (RPV) dosed monthly or every 2 months is a complete long-acting (LA) regimen for the maintenance of human immunodeficiency virus type 1 virologic suppression. Across the phase 3/3b trials, the most frequently reported adverse events were injection site reactions (ISRs). We present pooled ISR characteristics and outcomes for participants receiving CAB + RPV LA through week 96 of the FLAIR and ATLAS-2M studies, and survey results from healthcare providers (HCPs) giving injections (eg, injectors) in the ATLAS, FLAIR, and ATLAS-2M studies to determine optimal injection techniques. Surveys were anonymous, self-administered online questionnaires that queried provider demographics, injection experience, and techniques to minimize pre-/postinjection discomfort. Data were summarized using descriptive statistics. Overall, 8453 ISRs were reported by 801 participants receiving ≥1 injection of CAB LA/RPV LA. Most ISRs were mild to moderate in severity (grade 1-2, 99%), with a median duration of 3 days (interquartile range, 2-4 days), and rarely led to withdrawal (2%). Surveys were completed by 181 HCPs across 113 sites. Pushing the intramuscular injection at slow speed (66%), bringing the medication to room temperature (58%), and relaxing the gluteus muscle before injecting (53%) were ranked as effective preinjection/injection procedure practices for minimizing pain. Most injectors (60%) indicated that a prone position provided optimal patient comfort, and 41% had no preference on injection medication order. Taken together, the data demonstrate favorable tolerability with CAB + RPV LA injections over the long term and simple techniques routinely used by injectors to help optimize the administration of CAB + RPV LA injections.